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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-173726 | Other Identifier | Japic |
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To evaluate the long-term safety and tolerability of subcutaneous (SC) administration of TEV-48125 (at 225 mg once monthly [except for a loading dose of 675 mg for CM patients] or at 675 mg every 3 months) for the preventive treatment of Chronic Migraine and Episodic Migraine patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEV-48125 (225 mg/1 month) group | Experimental | TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly [except for a loading dose of 675 mg in subjects with CM]). |
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| TEV-48125 (675 mg/3 month) group | Experimental | TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEV-48125 | Drug | TEV-48125 will be administered subcutaneously once every 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With at Least One Treatment-Emergent Adverse Event (TEAE) |
| Baseline (Day 0) up to follow-up visit (Day 562) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Monthly (28 Day) Average Number of Migraine Days | Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications. |
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Inclusion Criteria:
Exclusion Criteria:
- Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator
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| Name | Affiliation | Role |
|---|---|---|
| Takehisa Matsumaru | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saitama Medical University Hospital | Iruma | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34687446 | Derived | Sakai F, Suzuki N, Ning X, Ishida M, Usuki C, Iba K, Isogai Y, Koga N. Long-Term Safety and Tolerability of Fremanezumab for Migraine Preventive Treatment in Japanese Outpatients: A Multicenter, Randomized, Open-Label Study. Drug Saf. 2021 Dec;44(12):1355-1364. doi: 10.1007/s40264-021-01119-2. Epub 2021 Oct 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TEV-48125 (225 mg/1 Month) Group | TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly [except for a loading dose of 675 mg in subjects with chronic migraine).](streamdown:incomplete-link) |
| FG001 | TEV-48125 (675 mg/3 Month) Group | TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TEV-48125 (225 mg/1 Month) Group | TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly [except for a loading dose of 675 mg in subjects with chronic migraine).](streamdown:incomplete-link) |
| BG001 | TEV-48125 (675 mg/3 Month) Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With at Least One Treatment-Emergent Adverse Event (TEAE) |
| Safety Set (SS): Newly enrolled subjects who received the IMP at least once | Posted | Number | percentage of participants | Baseline (Day 0) up to follow-up visit (Day 562) |
|
Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TEV-48125 (225 mg/1 Month) Group | TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly [except for a loading dose of 675 mg in subjects with chronic migraine).](streamdown:incomplete-link) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhegmatogenous retinal detachment | Eye disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pruritus | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 8, 2019 | Jun 27, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2019 | Jun 27, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000604315 | fremanezumab |
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| TEV-48125 | Drug | TEV-48125 will be administered subcutaneously once every 12 weeks. |
|
| Baseline, Month 12 |
| Mean Change From Baseline in the Monthly (28 Day) Average Number of Headache Days of at Least Moderate Severity | Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications. | Baseline, Month 12 |
| Protocol Violation |
|
| Withdrawal by Subject |
|
TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| TEV-48125 (675 mg/3 Month) Group |
TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months). |
|
|
| Secondary | Mean Change From Baseline in the Monthly (28 Day) Average Number of Migraine Days | Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications. | Full Analysis set (FAS): Newly enrolled subjects for whom electronic headache diary efficacy assessment data at baseline and after the first dose of IMP were available | Posted | Mean | Standard Deviation | days/month | Baseline, Month 12 |
|
|
|
| Secondary | Mean Change From Baseline in the Monthly (28 Day) Average Number of Headache Days of at Least Moderate Severity | Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications. | Full Analysis set (FAS): Newly enrolled subjects for whom electronic headache diary efficacy assessment data at baseline and after the first dose of IMP were available | Posted | Mean | Standard Deviation | days/month | Baseline, Month 12 |
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| 0 |
| 25 |
| 0 |
| 25 |
| 20 |
| 25 |
| EG001 | TEV-48125 (675 mg/3 Month) Group | TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months). | 0 | 25 | 2 | 25 | 16 | 25 |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
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| Injection site induration | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
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| Injection site erythema | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Ver. 22.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA Ver. 22.0 | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |